Efficacy and safety of implantable cardioverter-defibrillator implantation in the elderly-The I-70 Study: A randomized clinical trial.

Background: There is conflicting evidence on the efficacy of primary prevention implantable cardioverter-defibrillator (ICD) implantation in the elderly. Objective: The purpose of this study was to determine the efficacy and safety of ICD implantation in patients 70 years and older. Methods: Patients (n = 167) aged 70 years or older and eligible for ICD implantation were randomly assigned (1:1) to receive either optimal medical therapy (OMT) (n = 85) or OMT plus ICD (n = 82). Results: Of the 167 participants (mean age 76.4 years; 165 men), 144 completed the study protocol according to their assigned treatment. Average participant follow-up was 31.5 months. Mortality was similar between the 2 groups: 27 deaths in OMT vs 26 death in ICD (unadjusted hazard ratio 0.92; 95% confidence interval 0.53-1.57), but there was a trend favoring the ICD over the first 36 months of follow-up. Rates of sudden death (7 vs 5; P = .81) and all-cause hospitalization (2.65 events per participant in OMT vs 3.09 in ICD; P = .31) were not statistically significantly different. Eleven participants randomized to ICD received appropriate therapy. Five participants received an inappropriate therapy that included at least 1 ICD shock. Conclusion: The study did not recruit to target sample size, and accumulated data did not show benefit of ICD therapy in patients 70 years or older. Future studies similar in design might be feasible but will need to contend with patient treatment preference given the large number of patients who do not want an ICD implanted. Further research is needed to determine whether the ICD is effective in prolonging life among elderly device candidates.

Letter From Vienna.

The EPF 35th Annual Conference will be held in Vienna in July 2022 after it was postponed in 2020 due to the pandemic. All the greater is the pleasure to welcome you to the EPF Congress with the theme of Ideals this summer. The Vienna Psychoanalytical Society (WPV, Wiener Psychoanalytische Vereinigung) and the Vienna Psychoanalytical Association (WAP, Wiener Arbeitskreis für Psychoanalyse) would like to extend a warm invitation and welcome to Vienna, the birthplace of Psychoanalysis.

The SWIFT Model for Lichen Sclerosus Among Premenarchal Girls.

OBJECTIVE/PURPOSE: Delay in diagnosis of childhood lichen sclerosus (LS) can be ameliorated with an efficient evaluation tool. We sought to create a useful prognostic tool for rapid and accurate risk stratification for LS in premenarchal girls. METHOD: We conducted a retrospective chart review at a single institution of premenarchal girls presenting with vulvovaginal complaints at a specialty pediatric and adolescent gynecology clinic at a major academic center. Sixty-nine patients seen between July 2019 and September 2020 were used as a pilot study to create a model for LS based on 18 signs and symptoms. Accuracy of the pilot model was confirmed in a larger data set (additional 105 patients, seen between January 2017 and December 2020), and model parameters were refined through cluster-based analytics. RESULTS: Pilot study yielded 5 predictors for LS: soreness (S), whitening (W), urinary incontinence (I), fissures (F), and thickening of the clitoral hood (T)-SWIFT. The final refined model is given as log odds (LS) = -7 + 3·S + 17·W + 3·I + 3·F + 18·T. This model yielded a >97% accuracy in predicting LS among 174 unique patients (LS prevalence = 18%). CONCLUSIONS: The SWIFT model accurately predicts clinical diagnosis of LS in premenarchal girls. Replication in other patient populations is highly encouraged. Awareness of LS is paramount, and an efficient, accurate evaluation tool will prove invaluable in assuring timely diagnosis and treatment for premenarchal patients.

Coparenting Intervention for Expectant Parents Affects Relationship Quality: A Pilot Study.

Research has shown that the transition to parenthood is a particularly challenging period of life which is often associated with a decline in relationship quality and an increase in mental health problems. Emerging parents often experience difficulties in coping with new tasks and challenges in the relationship, resulting in inadequate mutual support, stress, conflicts and even depressive symptoms. To support expectant parents in establishing an effective and strong coparenting alliance, we have employed an educational coparenting intervention to teach important coparenting skills. The intervention was a non-randomized case-control study with 126 expectant parents. The intervention group participated in a five-session intervention, whereas the control group received an information booklet and had an optional meeting postpartum. The purpose of this study was to ease the transition to parenthood in order to prevent postpartum conflict and depression. Parents in the intervention group (n = 34 couples) showed significantly fewer conflicts postpartum than before (Z = -3.28, p = 0.00), and scored better in postnatal delegated dyadic coping (ß = 0.25, p = 0.00, R2 = 0.32), a form of mutual support. Neither the intervention group (Z = -0.83, p = 0.40) nor the control group (Z = -0.86, p = 0.38) showed a significant increase in depression scores after childbirth. Although conflicts during the transition to parenthood declined and postnatal delegated dyadic coping strengthened, the study design does not allow to draw conclusion on group effects. Nevertheless, the promising results of this pilot intervention are a base for future studies.

Influence of Nutrient Intake on 24 Hour Urinary Hydration Biomarkers Using a Clustering-Based Approach.

Previous work focusing on understanding nutrient intake and its association with total body water homeostasis neglects to consider the collinearity of types of nutrients consumed and subsequent associations with hydration biomarkers. Therefore, the purpose of this study was to analyze consumption patterns of 23 a priori selected nutrients involved in osmotic homeostasis, as well as their association with 24 h urinary hydration markers among fifty African-American first-year college students through a repeated measures observation in a daily living setting. Through application of hierarchical clustering, we were able to identity four clusters of nutrients based on 24 h dietary recalls: (1) alcohol + pinitol, (2) water + calcium + magnesium + erythritol + inositol + sorbitol + xylitol, (3) total calories + total fat + total protein + potassium + sodium + zinc + phosphorous + arginine, and (4) total carbohydrates + total fiber + soluble fiber + insoluble fiber + mannitol + betaine. Furthermore, we found that consumption of nutrients in Cluster #2 was significantly predictive of urine osmolality (p = 0.004); no other clusters showed statistically significant associations with 24 h urinary hydration biomarkers. We conclude that there may be some nutrients that are commonly consumed concomitantly (at the day level), across a variety of settings and populations, and that a limited subset of the clustering of these nutrients may associate with body water status.

Impact of Nutrient Intake on Hydration Biomarkers Following Exercise and Rehydration Using a Clustering-Based Approach.

We investigated the impact of nutrient intake on hydration biomarkers in cyclists before and after a 161 km ride, including one hour after a 650 mL water bolus consumed post-ride. To control for multicollinearity, we chose a clustering-based, machine learning statistical approach. Five hydration biomarkers (urine color, urine specific gravity, plasma osmolality, plasma copeptin, and body mass change) were configured as raw- and percent change. Linear regressions were used to test for associations between hydration markers and eight predictor terms derived from 19 nutrients merged into a reduced-dimensionality dataset through serial k-means clustering. Most predictor groups showed significant association with at least one hydration biomarker: 1) Glycemic Load + Carbohydrates + Sodium, 2) Protein + Fat + Zinc, 3) Magnesium + Calcium, 4) Pinitol, 5) Caffeine, 6) Fiber + Betaine, and 7) Water; potassium + three polyols, and mannitol + sorbitol showed no significant associations with any hydration biomarker. All five hydration biomarkers were associated with at least one nutrient predictor in at least one configuration. We conclude that in a real-life scenario, some nutrients may serve as mediators of body water, and urine-specific hydration biomarkers may be more responsive to nutrient intake than measures derived from plasma or body mass.

Models of hydration and nutrition require environmental data.

OBJECTIVE: To recognize the causality of environmental factors (i.e. temperature, humidity and sun exposure) on nutritional variables, specifically body water balance and water-seeking behaviour. DESIGN: Author perspective. SETTING: Global. PARTICIPANTS: Not applicable. RESULTS: A free-standing code supplement is provided to facilitate investigators in accessing meteorological data for incorporation into analyses related to nutrition and hydration. CONCLUSIONS: Analytical models related to human hydration should account for the environment de rigueur.

Unexplained Variance in Hydration Study.

With the collection of water-intake data, the National Health and Nutrition Examination Survey (NHANES) is becoming an increasingly popular resource for large-scale inquiry into human hydration. However, are we leveraging this resource properly? We sought to identify the opportunities and limitations inherent in hydration-related inquiry within a commonly studied database of hydration and nutrition. We also sought to critically review models published from this dataset. We reproduced two models published from the NHANES dataset, assessing the goodness of fit through conventional means (proportion of variance, R2). We also assessed model sensitivity to parameter configuration. Models published from the NHANES dataset typically yielded a very low goodness of fit R2 < 0.15. A reconfiguration of variables did not substantially improve model fit, and the goodness of fit of models published from the NHANES dataset may be low. Database-driven inquiry into human hydration requires the complete reporting of model diagnostics in order to fully contextualize findings. There are several emergent opportunities to potentially increase the proportion of explained variance in the NHANES dataset, including novel biomarkers, capturing situational variables (meteorology, for example), and consensus practices for adjustment of co-variates.

Taxonomy of clinical encounters during the first 90 days post-delivery of an initial lower limb prosthesis.

BACKGROUND: The incidence and etiology of prosthetic services utilization is poorly understood during the first 90 days post-delivery of the initial lower limb prosthesis. This period is of critical importance, as prevailing policy dictates limits on the reimbursement for certain services provided during this time period. The first step in understanding the financial ramifications of such policy is to examine the taxonomy behind clinical encounters during this tenuous time period. OBJECTIVES: Quantify and categorize clinical encounters by incidence and etiology. STUDY DESIGN: Retrospective chart review. METHODS: A central database containing data on prosthetic services was examined. Incidence and etiology were extracted through independent review of each patient chart. RESULTS: A total of 537 unique patients were identified, with 109 meeting the inclusion criteria. Chi-square testing showed that comfort ( p < 0.05), cosmesis ( p < 0.01), and mechanical failure ( p < 0.001) yielded statistical significance in scheduled versus unscheduled visits. Stepwise regression analysis demonstrated that both sex and K-level were important predictors of unscheduled visits. CONCLUSION: Taxonomization of clinical encounters experienced during the first 90 days provides a framework for future studies to be conducted. The data provided can serve as a basis for informing reimbursement policy, workforce planning, and advocacy. Clinical relevance Comfort is the most frequent reason for a clinical encounter during the first 90 days after delivering a lower limb prosthesis. The data on the taxonomy behind the clinical encounters can be used to guide workforce planning and advocate for just reimbursement policy that better reflect patient's needs.

Clustering of Directions Improves Goodness of Fit in Kinematic Data Collected in the Transverse Plane During Robot-Assisted Rehabilitation of Stroke Patients.

The kinematic character of hand trajectory in reaching tasks varies by movement direction. Often, direction is not included as a factor in the analysis of data collected during multi-directional reach tasks; consequently, this directionally insensitive model (DI) may be prone to type-II error due to unexplained variance. On the other hand, directionally specific models (DS) that account separately for each movement direction, may reduce statistical power by increasing the amount of data groupings. We propose a clustered-by-similarity (CS) in which movement directions with similar kinematic features are grouped together, maximizing model fit by decreasing unexplained variance while also decreasing uninformative sub-groupings. We tested model quality in measuring change over time in 10 kinematic features extracted from 72 chronic stroke patients participating in the VA-ROBOTICS trial, performing a targeted reaching task over 16 movement directions (8 targets, back- and forth from center) in the horizontal plane. Across 49 participants surviving a quality control sieve, 4.3 ± 1.1 (min: 3; max: 7) clusters were found among the 16 movement directions; clusters varied between participants. Among 49 participants, and averaged across 10 features, the better-fitting model for predicting change in features was found to be CS assessed by the Akaike Information criterion (61.6 ± 7.3%), versus DS (31.0 ± 7.8%) and DI (7.1 ± 7.1%). Confirmatory analysis via Extra Sum of Squares F-test showed the DS and CS models out-performed the DI model in head-to-head (pairwise) comparison in >85% of all specimens. Thus, we find overwhelming evidence that it is necessary to adjust for direction in the models of multi-directional movements, and that clustering kinematic data by feature similarly may yield the optimal configuration for this co-variate.

Parent handling of typical infants varies segmentally across development of postural control.

Although trunk muscles extend across multiple vertebral joints, recent motor control studies have shown that a top-down progression of trunk control in typical infants occurs incrementally, one segment at a time, until independent sitting. The current study merges this surprising developmental pattern with parent behavior by exploring the relationship between how parents hold their infant and the segmental level for which the infant exhibits postural control. We measured trunk control of 60 infants (1-8 months) via the segmental assessment of trunk control. Spontaneous parental hold and variability was recorded during repeated sitting and standing conditions. Parent hold correlated with infant level of control in both sitting and standing, providing evidence for a positive interaction between parent behavior and segmental trunk development.

The Geek Perspective: Answering the Call for Advanced Technology in Research Inquiry Related to Pediatric Brain Injury and Motor Disability.

The Academy of Pediatric Physical Therapy Research Summit IV issued a Call to Action for community-wide intensification of a research enterprise in inquiries related to pediatric brain injury and motor disability by way of technological integration. But the barriers can seem high, and the pathways to integrative clinical research can seem poorly marked. Here, we answer the Call by providing framework to 3 objectives: (1) instrumentation, (2) biometrics and study design, and (3) data analytics. We identify emergent cases where this Call has been answered and advocate for others to echo the Call both in highly visible physical therapy venues and in forums where the audience is diverse.

Filtering for productive activity changes outcomes in step-based monitoring among children.

Wearable activity monitors are increasingly prevalent in health research, but there is as yet no data-driven study of artefact removal in datasets collected from typically developing children across childhood. Here, stride count data were collected via a commercially available activity monitor (StepWatch), which employs an internal filter for sub-threshold accelerations, but does not post-process supra-threshold activity data. We observed 428 typically-developing children, ages 2-15, wearing the StepWatch for 5 consecutive days. We developed a minimum per-minute stride-count below which the data outputted from the StepWatch could be considered 'idle' and not 'productive'. We found that a threshold stride count of 10 steps per minute captured 90% of samples in a weighted average among isolated non-zero stride-count samples offset by inactivity. This threshold did not vary by age, gender, or by an age-gender interaction. Filtering the activity data according to this threshold reduced overall stride count by 8-10% by age group, from 8177 ± 2659 to 7432 ± 2641 strides per day. The impact on number of bouts per day decreased from an overall average of 79.3 ± 17.2 to 72.7 ± 12.1; this effect varied by age group. This study delivers the first data-driven estimate of a minimum activity threshold in step- or stride units that may extend to other studies. We conclude that the impact of production-idle filtering on activity data is substantial and suggests a possible impetus for re-contextualizing extant studies and guidelines reported without such filtering.

Orthotic-Style Off-Loading Wheelchair Seat Cushion Reduces Interface Pressure Under Ischial Tuberosities and Sacrococcygeal Regions.

OBJECTIVE: To assess the efficacy of an off-loading wheelchair seat cushion in removing pressure from high-risk ischial tuberosities and the coccyx/sacrum in wheelchair sitting. DESIGN: Repeated-measures design. SETTING: Private research laboratory. PARTICIPANTS: Manual wheelchair users with chronic spinal cord injuries (N=10). INTERVENTIONS: Three configurations of an off-loading wheelchair seat cushion compared with a flotation style (10-cm air inflation) wheelchair seat cushion. MAIN OUTCOME MEASURES: Outcome measures included peak pressure index (PPI), ischial tuberosity peak pressures, and the dispersion index or ratio of pressures under the ischial and sacral regions to the total of all pressures recorded. RESULTS: PPI and ischial tuberosities peak pressure ranged from a low of 39±18 and 68±46mmHg in the fully off-loaded cushion to a high of 97±30 and 106±34mmHg, respectively, for the flotation style cushion (2-way analysis of variance main effect across 4 conditions, P<.001). Dispersion index ranged from a low of 8%±3% in the fully off-loaded cushion to a high of 16%±3% in the flotation style cushion. Pairwise comparisons yielded significance in all cushion-pair analyses (P<.05 after multiple corrections). CONCLUSIONS: The force-removal approach of this orthotic off-loading cushion design effectively reduces a known extrinsic risk factor for pressure ulcers-interface pressure-in the high-risk ischial tuberosity and sacral/coccygeal regions of the buttocks.